Plans scale with the number of concurrent active studies. Annual billing saves 20% compared to monthly.
For teams managing 1–2 concurrent Phase I or II studies.
For Phase II–III programs with multiple active studies and multi-site operations.
For CROs and large pharma organizations managing 10+ studies concurrently.
Annual billing available: save 20% on Starter and Growth plans. All prices in USD.
A study is active if it has had at least one data ingestion event in the current billing month. Studies in setup, closeout archiving, or that have been locked and archived do not count toward your plan limit. You can deactivate a study at any time and it will stop counting on the next billing cycle.
Yes. Plan upgrades take effect immediately. You will be charged a prorated amount for the remainder of the billing period. All your existing study configurations, validation rules, and audit trail data carry over without any migration steps required.
A Business Associate Agreement (BAA) is available under the Enterprise plan for organizations that process Protected Health Information. Starter and Growth plan environments use pseudonymized subject IDs consistent with clinical trial data standards; identifiable patient data should not be stored in these tiers. If your study design requires identifiable data in the platform, please contact us to discuss the Enterprise plan and associated BAA terms before onboarding.
The Growth plan free trial is 21 days, full-featured. You can connect your EDC, configure SDTM mappings, run validation against real study data, and generate CDISC-compliant exports. The trial environment includes the same GAMP 5 validation documentation as a paid subscription. No payment method is required to start. If you choose not to continue, your configuration and audit trail data are retained for 90 days in case you wish to re-activate.
Most teams complete EDC connection, initial SDTM mapping configuration, and their first automated validation run within 5 business days. The critical path is usually getting API credentials from your EDC vendor — MLPipeKit's onboarding team can work directly with your Medidata, Oracle, or Veeva account representative to accelerate that process. Growth plan customers are assigned a CDM specialist who guides the setup.
No. MLPipeKit is validated under GAMP 5 Category 4 at the platform level. You receive a base validation package (IQ/OQ/PQ) that covers the platform's core functions. Study-specific configurations (SDTM mapping specs, validation rules) are treated as Operational Qualification items you manage. When we release platform updates, we provide an impact assessment and supplemental test scripts covering changed functionality — you do not repeat the full validation cycle for unaffected features.
Full Growth plan access. No credit card required. Our CDM specialist joins you for the first setup session.